A Study With RO4917523 in Patients With Fragile X Syndrome | NCT01015430

Studies
A Study With RO4917523 in Patients With Fragile X Syndrome

NCT01015430

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Fragile X Syndrome

Interventions

Placebo (for RO4917523 ascending doses)
Placebo (for RO4917523 fixed dose)
RO4917523
RO4917523

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 17, 2009

First Posted Date

Nov 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jul 6, 2016

Certification/Extension First Submitted that Passed QC Review

Jul 6, 2016

Certification/Extension First Posted Date

Jul 11, 2016Estimated

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This randomized, double-blind multiple ascending dose study will evaluate the safety and tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome. The patients will be randomized to receive either active drug or placebo. The anticipated time on study treatment is 6 weeks. The target sample size is <100 patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo (for RO4917523 ascending doses)	Placebo Comparator	Drug: Placebo (for RO4917523 ascending doses) Drug: Placebo (for RO4917523 fixed dose)
Placebo (for RO4917523 fixed dose)	Placebo Comparator	Drug: Placebo (for RO4917523 ascending doses) Drug: Placebo (for RO4917523 fixed dose)
RO4917523 ascending doses	Experimental	Drug: RO4917523
RO4917523 fixed dose	Experimental	Drug: RO4917523

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo (for RO4917523 ascending doses)	Drug	Placebo daily po	Placebo (for RO4917523 ascending doses) Placebo (for RO4917523 fixed dose)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters		AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: Behavior and cognition assessments		Every 2 weeks throughout study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, 18 to 50 years of age
Fragile X Syndrome
IQ less than 75
Reliable caregiver

Exclusion Criteria:

Current psychosis or presumption of psychosis
History of suicidal behavior or considered a high suicidal risk
Severe self-injurious behavior
Any unstable medical condition other than Fragile X Syndrome (e.g. hypertension, diabetes)
Current seizure disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Sacramento	California	95817	United States

Condition Browse Module

MeSH Terms

ID	Term
D005600	Fragile X Syndrome

Ancestor Terms

ID	Term
D038901	X-Linked Intellectual Disability
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000596770	2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided